The Prostate Cancer Clinical Trials Consortium: Application for Coordinating Center with Affiliate Clinical Research Sites
Abstract
Accelerating drug development through multicenter collaboration. The Prostate Cancer Clinical Trials Consortium (PCCTC) brings together the nation’s leading prostate cancer investigators to fulfill a single mission to design, implement, and complete innovative clinical trials in prostate cancer, translating scientific discoveries to improved standards of care. Since its inception in 2005, the PCCTC has been led by Principal Investigator Howard I. Scher, M.D., Head of the Biomarker Development Program and D. Wayne Calloway Chair in Urologic Oncology at Memorial Sloan Kettering Cancer Center (MSK). Dr. Scher’s renowned insight into prostate cancer biology and expertise in treating men with advanced disease allows the PCCTC to select the most promising drug development opportunities based on the strength of the science. Multicenter collaboration and the Consortium’s proven ability to accelerate and streamline the clinical trial process are made possible through the constant refinement of the PCCTC Coordinating Center’s infrastructure. To allow the PCCTC to fulfill its mission, the Coordinating Center addresses the scientific, legal, regulatory, data, budgetary, and management obstacles of investigators throughout its network of over 70 Clinical Research Sites. Our approach has enabled the PCCTC to review 346 protocols, approve 280 for activation, and enroll over 11,047 men to 234 trials as of August 2021. Critically, we have contributed to the unprecedented advancement of 27 therapeutic candidates to phase 3 study, seven of which — Zytiga, Xtandi, Erleada, Jevtana, Xofigo, Rubraca, Lynparza — are fully approved and an additional one, Niraparib, has received a Breakthrough Designation from the U.S. Food A Drug Administration (FDA) — approved for treatment of men with castration-resistant prostate cancer (CRPC). Developing treatments that improve outcomes for men with lethal prostate cancer. MSK recruits into research studies men who have prostate cancer and have had disease progression despite other treatments, men who have types of disease for which no accepted therapy exists, or men who cannot have standard therapy because it is too toxic or too risky. Equally important has been our work with regulatory authorities (the FDA and the National Cancer Institute) in developing (a) biomarkers that could be used for evaluating how drugs work and getting them approved for general use and (b) test used to guide treatment selection for the individual patient (i.e., personalized medicine). All patients in our trials gain access to our diagnostic resources and receive treatments that are not otherwise available, which could extend their lives or improve their quality of life. Advancing health equity and reducing disparities in prostate cancer. The PCCTC tasks itself with improving care for patients from disproportionately affected populations. As such, MSK and the entire Consortium are actively enrolling African-American men, a group that has had high rates of prostate cancer. Our selected Affiliate Clinical Research Sites — the University of California San Diego and Tulane Medical School — will notably enhance the impact of the PCCTC in this area by serving their uniquely high-risk and underserved patient populations, combined with their demonstrated commitment to addressing inequities in research and health care. Ensuring the long-term viability of the PCCTC’s collaborative drug development paradigm. In 2014, the Coordinating Center established an independent entity, the Prostate Cancer Clinical Trials Consortium, LLC, to secure and expand our enhancements to the clinical trial environment, to become financially self- sufficient, as stipulated by the Consortium’s previous funding mechanism, and to achieve long-term viability. We aim to maintain our viability by making further enhancements to our data management, correlative science, and regulatory programs. Making a significant impact. By implementing an organ
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2220020
Entities
People
- Howard Scher
Organizations
- Sloan-Kettering Institute
- United States Army